The following background information may present examples of specific aspects of the prior art (e.g., without limitation, approaches, facts, or common wisdom) that, while expected to be helpful to further educate the reader as to additional aspects of the prior art, is not to be construed as limiting the present invention, or any embodiments thereof, to anything stated or implied therein or inferred thereupon.
It is known in the art that diabetic retinopathy is a leading cause of blindness in the world. The prevalence of diabetes continues to increase throughout the world. The most recent report finds 50% of Americans have diabetes or pre-diabetes. Typically, the incidence of diabetic retinopathy is directly related to the duration of the illness. Diabetic retinopathy occurs in up to 80% of patients suffering from diabetes for over 10 years. The disease occurs even in patients with excellent control of blood sugar. Most patients can expect to suffer from the retinopathy over the course of the illness.
Currently there is no method available to prevent the onset of diabetic retinopathy. Also treatment is not available until the retinopathy becomes very severe. Then invasive treatment options will be laser photocoagulation to destroy the ischemic portion of the retina, vitrectomy, and intravitreal injections of medications such as steroids to salvage the central vision.
Generally, the protein deposits, i.e., hard exudates, are located in the foveal region. Treatment at the foveal region may be difficult with lasers without damaging the foveal region. Also laser scars may spread out over time eventually damaging the fovea causing permanent loss of central vision. Also laser photocoagulation destroys the retina and causes permanent damage to the peripheral and paracentral portion of vision. There is also a limit to the number of laser treatments that can be performed.
Generally, vitrectomy and intravitreal injections all carry severe potential complications including infection (endophthalmitis), bleeding, retinal detachment, blindness and loss of the eyeball. Even with laser photocoagulation and invasive surgical procedures, most patients can only hope for some or limited visual improvement.
Since diabetic retinopathy cannot be arrested permanently using even the most aggressive procedures, the retinopathy can continue to progress eventually causing permanent blindness. I many instances, it is much more desirable to re-perfuse the ischemic retina rather than destroying it. Therefore there is a very urgent need for a treatment method to prevent and reverse diabetic retinopathy and other vascular retinopathies using non-invasive means.
Other proposals have involved treatment of diabetic retinopathy. The problem with these treatments is that they are invasive and cause damage to the foveal region; especially with laser treatment. Even though the above cited treatments for diabetic retinopathy meet some of the needs of the market, a noninvasive method that prevents and reverses diabetic retinopathy and other vascular retinopathies using a series of non-invasive light and oxygen treatments and compositions to create a synergetic effect for the patient is still desired.